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510(k) Data Aggregation

    K Number
    K192557
    Device Name
    Youjia Unscented Tampon with Plastic Applicators
    Date Cleared
    2020-02-13

    (149 days)

    Product Code
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qingdao Youjia Hygiene Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Youjia unscented tampon with plastic applicators are inserted into the vagina and used to absorb menstrual and other vaginal discharge.
    Device Description
    Youjia unscented tampon with plastic applicators are composed of an absorbent pledget (tampon), a withdrawal cord and an applicator. The pledgets have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. These tampons are provided in three absorbencies: regular (6-9g), super, (9-12g), and super plus (12-15g). Each tampon is individually wrapped and packaged. The Youjia unscented tampon with plastic applicators are provided non-sterile and for single use only.
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    K Number
    K190218
    Device Name
    Unscented Menstrual Tampon
    Date Cleared
    2019-05-09

    (94 days)

    Product Code
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qingdao Youjia Hygiene Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
    Device Description
    The BiuBiu tampon is composed of an absorbent pledget (tampon), a withdrawal cord, and an applicator. The pledgets (cleared under K090819) have a cylindrical, bullet-like shape and the applicators have a smooth, rounded tip to ease insertion. The barrel of the applicator has a no-slip grip design to help hold the tampon tightly. Each tampon is individually wrapped and packaged. There are three versions of the BiuBiu tampon with different absorbencies: regular, super and super plus. Each version has a different color applicator. The BiuBiu tampon is provided non-sterile and for single use only.
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